Exercise and Nutritional Intervention for Deconditioned Older Adults

April 11, 2012 updated by: US Department of Veterans Affairs

An Exercise and Nutritional Intervention for Deconditioned Older Adults

In this study we will evaluate whether the addition of a formal lower extremity resistance exercise training program and/or a nutritional supplement will improve the functional recovery of older adult veterans participating in a geriatric rehabilitation program for deconditioning. Specifically, subjects admitted to a geriatric inpatient rehabilitation program with a diagnosis of deconditioning will be randomly assigned to one of four groups; 1) Control/standard rehabilitation program, 2) Standard rehabilitation plus resistance exercise twice per week, 3) Standard rehabilitation plus a daily nutritional supplement, 4) Standard rehabilitation plus the resistance exercise and the nutritional supplement. Subjects will participate in each program for 12 weeks. At the beginning and end of the study we will measure lower extremity strength, walking speed, and overall function (using the standardized Functional Independence Measure), and compare the changes in each group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • No. Little Rock, Arkansas, United States, 72114-1706
        • Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Veteran admitted to GEM rehabilitation unit
  • Primary problem: Deconditioning/Generalized Weakness
  • Age 65-90
  • Self reported ability to report to the CAVHS GRECC twice per week after discharge from the GEM unit.
  • Living in the community prior to recent acute care hospitalization
  • Decision making capacity to be able to consent to the study as documented in the GEM attending or GEM APN's admission note

Exclusion Criteria:

  • Conditions that are exclusionary criteria for GEM admission including the following: direct transfer from any ICU, end-stage chronic medical/surgical disorder with no rehabilitation potential, terminal diagnosis /hospice/respite care, hemodialysis, active radiation therapy. Also, Type I diabetes mellitus
  • Any other condition considered exclusionary by the PI / study physician.

Prior to group assignment, subjects will be evaluated for contraindications to exercise training per the American College of Sports Medicine (ACSM)guidelines including the following:

  • Myocardial infarction documented in the past 3 months
  • Unstable angina (at rest in past 3 months, or increased angina pattern in past month)
  • Uncorrected left main coronary obstruction > 50%;
  • Congestive heart failure exacerbation in past 3 months (symptoms at rest or worsening symptoms requiring change in baseline diuretic dose)
  • Severe valvular heart disease (aortic or mitral stenosis with valve area < 1 cm2 , mitral or aortic insufficiency with any degree of LV dysfunction, pulmonary hypertension [PASP > 50 mmHg], or LV enlargement [LVESD 40 mm, or LVEDD > 55 mm])
  • Active pericarditis / myocarditis
  • Malignant or unstable arrhythmias, third degree AV block without pacemaker
  • Elevated resting blood pressure (systolic > 200 mmHg, diastolic > 110 mmHg)
  • Known large (> 4 cm) aortic aneurysm
  • Known cerebral aneurysm or intracranial bleed in past 1 year
  • Terminal cancer
  • Acute retinal hemorrhage or ophthalmologic surgery within 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 1
Control inpatient GEM rehabilitation and continue twice weekly low level walking/stretching to control for time/interaction with intervention/exercise groups
Experimental: 2
Resistance exercise (2x/week)
Other: Resistance exercise
Lower extremity resistance exercise (leg press/knee extension) twice per week for 12 weeks
Experimental: 3
Nutritional (amino acid metabolite) supplement twice daily
Dietary supplement: Protein and HMB (see below) supplement
Ingested twice daily for 12 weeks Active components include: Protein and B-hydroxy-B -methylbutyrate
Experimental: 4
Resistance exercise (2x/week) and nutritional (amino acid metabolite) supplement twice daily
Other: Resistance exercise
Lower extremity resistance exercise (leg press/knee extension) twice per week for 12 weeks
Dietary supplement: Protein and HMB (see below) supplement
Ingested twice daily for 12 weeks Active components include: Protein and B-hydroxy-B -methylbutyrate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Function by the Functional Independence Measure
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Gait speed
Time Frame: 12 weeks
12 weeks
Lower extremity strength
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
US Department of Veterans Affairs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick Kortebein, MD, Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E7142-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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